- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05728619
HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer
September 26, 2023 updated by: Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
A Phase 1b/2, Dose-finding and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HTMC0435 With Temozolomide in Patients With Small Cell Lung Cancer
The Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred).
The Phase 2 part of the study is a multi-center, open-label, single-arm trial to investigate the preliminary efficacy of HTMC0435 and temozolomide in patients with recurrent small cell lung cancer (SCLC) at the recommended phase 2 dose.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Li
- Phone Number: +86-21-64311017
- Email: clinical_trial@hllife.com.cn
Study Locations
-
-
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Hangzhou, China
- Recruiting
- Zhejiang Cancer Hospital
-
Nanjing, China
- Recruiting
- Jiangsu Province Hospital of Chinese Medicine
-
Zhengzhou, China
- Recruiting
- Henan Cancer Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female, age ≥18 and <75 years old
- Patients with histologically or cytologically confirmed recurrent or progressive extensive-stage SCLC, who have previously received at least first-line and no more than second-line treatments (HRR mutations are preferred)
- [Only applicable to phase II part] At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~1
- Expected survival period ≥3 months
- Prior to the enrollment, no serious hematopoietic abnormality, and generally normal function of heart, lung, liver and kidney
- Understand and sign the informed consent form (ICF) voluntarily. Be willing and able to complete routine visits, treatment plans, laboratory examinations and other procedures.
Exclusion Criteria:
- Prior treatment with any poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
- Prior temozolomide treatment interruption caused by toxicity
- Received treatment with chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy ≤4 weeks prior to the first dose of HTMC0435
- Any unrecovered AE of prior therapy ≥CTCAE 5.0 Grade 1 (except for toxicity that the investigators judged to have no safety risks, such as alopecia)
- Currently suffering from interstitial lung disease ≥CTCAE Grade 2
- Major surgery (excluding needle biopsy) within 4 weeks before the first dose of HTMC0435
- Past surgical history or severe gastrointestinal diseases that the investigator believes may affect the absorption, distribution or metabolism of the study drug, such as dysphagia, active gastric ulcer, ulcerative colitis, Crohn's disease, ileus, etc.
- History of severe cardiovascular and cerebrovascular diseases
- Received CYP3A4 potent inhibitors or inducers within 7 days before the first dose of HTMC0435 or need to use these medications during the study
- Symptomatic brain metastases or meningeal metastases. Patients with these metastases who have received related treatment need to meet the following conditions before they can be enrolled: no radiographic evidence of progression ≥ 4 weeks after the end of treatment; completion of treatment ≥ 28 days before the first dose; no need for systemic corticosteroids treatment (>10 mg/day prednisone or equivalent dose) within 14 days before the first dose of HTMC0435
- Active infectious diseases which need systemic anti-infection treatment
- Hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) -DNA >1000 copies/mL or >200 IU/mL; hepatitis C virus antibody (HCV-Ab) positive
- Human immunodeficiency virus antibody (HIV-Ab) positive
- Previous or current diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML)
- Women who are pregnant or breastfeeding; women/men who are planning to have a child; women/men who refuse to use medically approved contraceptive measures for contraception during the study treatment and within 6 months after the end of the study
- Serious psychological or mental abnormalities that may affect compliance of patients in this study
- Current alcohol or drug abusers
- Judgment by the investigator that the patient is not suitable for this study due to other conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1b
Escalating doses of HTMC0435 and Temozolomide
|
Oral administration.
Oral administration.
|
Experimental: Phase 2
Recommended phase 2 dose (RP2D) of HTMC0435 and Temozolomide
|
Oral administration.
Oral administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 21
|
Cycle 1 Day 1 to Cycle 1 Day 21
|
Adverse events (AE) of HTMC0435 combined with Temozolomide
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time infinity (AUC 0-inf)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time t (AUC 0-t)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - apparent clearance rate (CLz/F)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - maximum plasma concentrations (Cmax)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - time to reach Cmax (Tmax)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - trough concentrations at steady state (Css, min)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - peak concentrations at steady state (Css, max)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - accumulation ratio (Rac)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - terminal plasma half-life (T1/2)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Pharmacokinetic measures - apparent volume of distribution during terminal phase (Vz/F)
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 9
|
Cycle 1 Day 1 to Cycle 1 Day 9
|
Objective response rate (ORR) by RECIST v1.1
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Disease control rate (DCR) by RECIST v1.1
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Progression-free survival (PFS) by RECIST v1.1
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Duration of response (DOR) by RECIST v1.1
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Overall survival (OS) by RECIST v1.1
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in neuron-specific enolase (NSE) level from baseline
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Changes in pro-gastrin-releasing peptide (PROGRP) level from baseline
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yun Fan, MD, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
January 10, 2023
First Submitted That Met QC Criteria
February 5, 2023
First Posted (Actual)
February 15, 2023
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- HLND-01-TMZ-Ib/II-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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